Mild Cognitive Impairment Clinical Trial
Official title:
A 6 Month, Phase II Randomized, Double-Blind, Placebo Controlled, Flexible Dosing, Crossover Trial of Atomoxetine in Subjects With Mild Cognitive Impairment.
The purpose of this study is to evaluate the safety of atomoxetine and its effect primarily on the biologic markers (substances that may indicate the presence of a disease) in the cerebrospinal fluid (CSF) of participants diagnosed with Mild Cognitive Impairment (MCI). Additionally, information will be gathered to identify the dose of atomoxetine that is most beneficial, and how taking this medication affects thinking and behavior, as well as imaging and blood biomarkers.The study will also explore rates of change in biomarkers of neurodegeneration (Aß, tau, brain atrophy rates). The results of this research will help determine if atomoxetine alters signs of inflammation and other biomarkers associated with Alzheimer's disease.
The Alzheimer's Disease (AD) epidemic is a looming crisis, with an urgent need for new
therapies to delay or prevent symptom onset and progression. Advances in AD biomarker
research have demonstrated changes in amyloid, brain metabolism, and other pathophysiologies
prior to the onset of memory loss, with some markers possibly changing one or two decades
earlier. Since MCI coincides with the onset of brain atrophy, this early stage of AD
pathogenesis may offer a critical window of time to initiate novel therapies aimed at the
secondary wave of events that lead to progressive neurodegeneration.
From recently emerged basic research in animal models of AD: loss of norepinephrine (NE)
incites a pro-inflammatory condition that is neurotoxic and reduces Aß clearance, and
remarkably, rescue of norepinephrine reverses these effects and slows neurodegeneration. This
study seeks to extend this proof-of-concept to humans for the first time. The study proposes
that atomoxetine, a selective norepinephrine transport inhibitor, is an ideal drug to
translate these findings to humans because it is already FDA-approved and safe in the elderly
Subjects with mild cognitive impairment (amnestic or multi-domain subtypes) will be randomly
assigned to treatment with placebo or flexible doses of the Norepinephrine Transporter (NET)
inhibitor atomoxetine, starting with 10 mg po daily and increasing weekly by increments to a
maximum of 100 mg po daily or the maximum tolerated dose. Participants will be treated for
upto 29 weeks, and will undergo venous blood draws and lumbar puncture for biomarker analyses
at baseline and up to weeks 29. At a maximum of 29 weeks time point, subjects assigned to
active treatment will crossover to placebo and those subjects who were initially randomized
to placebo will initiate active treatment.
Participants who complete study are eligible to receive open-label Atomoxetine at the
maximum-tolerated dose received during the double-blind phase of the trial. Subjects in the
open label are seen every at week 29 upto maximum of 2 years.
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